Clinical trial data is vital for patient safety and clinical research. But there are many challenges in managing and sharing that data. This post will cover the importance of clinical trial data and why it should be controlled electronically. We will also discuss why data management is vital in the clinical research process and what you can do to improve your organisation’s data management.
Electronic patient-reported outcomes (ePRO) describe various clinical trial devices that strive to introduce virtual reporting. ePRO enables patients to report and discuss the state of their health via their electronic devices such as smartphones, computers or tablets. This technology aims to substitute the traditional usage of paperwork.
The Benefits of using ePRO Clinical Trial Data
The ePRO software offers several benefits to its users by collecting relevant information about the progress of their treatment, health or the patient’s experience. Keep reading to understand how users will benefit from the ePRO software.
ePRO Increases Patient Safety and Provides Real-Time Data
The new developments in smart device technology improve the patient’s safety by enabling the digitised collection of data. ePRO allows health practitioners and researchers to receive patient data in real-time. Hence, this mitigates any possible harm by monitoring the patient’s symptoms and responding to them swiftly. For instance, some ePRO devices monitor the heart rate, range of motion and stop motion.
The Software Improves the Patients’ Experience
Most patients prefer ePRO solutions since they are convenient and are more accessible. However, this technology experiences a setback considering that patients may lack continued access to internet connection or smart devices. The researchers and health providers can opt to supply the patients with the ePRO pieces of equipment during the trial period.
Improved Patient Protocol Compliance and Data Quality
Protocol compliance rates of the patients using paper diaries and ePRO diaries are different. The patients using eDiary have a higher compliance rate which means using ePRO solutions in clinical trials boosts patient protocol compliance and results in quality data. The paper diaries were digitally powered and allowed insights into how the patients completed their entries. The researchers’ ability to monitor and track the participants’ data revealed information about late entry submissions and data falsification in paper diaries; thus, compliance requirements were not met.
Trial Cost Reduction
ePRO aims to reduce the cost of data monitoring and data collection. The software lowers costs by eliminating the need for smart devices provided and assigned to patients by sponsors. Hence, there is no need to track and control devices. ePRO reduces data duplication and mistakes that are likely to occur during the collection of outcomes from patients. The electronic device allows only the collection of pertinent data, thus reducing the resources responsible for data collection.
Importance of Data Management in Clinical Research Process
Managing data efficiently in the clinical research process is essential in making the right decisions and bringing forth meaningful solutions. Incorrect and breached data will result in wrong choices, which will be challenging to come up with suitable solutions.
Visibility – Data management allows visibility of data assets in the research process, making it easier for the researchers to quickly and confidently find the correct data for their analysis. Well organised data increases the productivity of the researchers.
Security – data management prevents the data from being breached, stolen and lost with authentication and encryption tools. Robust data security ensures the research data is backed up and can be retrieved in case the primary source becomes unavailable.
Reliability – reliable and up to date data enables researchers to respond more efficiently to health industry changes and patients’ needs. Besides, reliability reduces potential errors by establishing policies and processes of usage, therefore creating trust in the data being used to make decisions in the entire research process.
Scalability – allows effective scaling of data. It prevents the unnecessary cost of duplication, such as researchers conducting the same research repeatedly or re-running unnecessary costly queries.
How to Improve Data Management in an Organisation
• Build a data management team that is skilled
• Ensure that your organisation complies with global data privacy regulation
• Ensure security of your organisation’s data by utilising data protection tools
• It is essential to understand the potential of the data you have
